Disposable suction valve for an endoscope

ABSTRACT

A disposable suction valve is provided. In some embodiments, the disposable suction valve may include a stem providing an air passage through the stem, a spring, a spring stanchion cup, and a boot. A method for manufacturing a disposable suction valve may include several steps. A stem and spring stanchion cup are molded, and a bottom end of the stem is placed through the center of a spring. The bottom end of the stem is placed through a stem opening in the spring stanchion cup, and the tabs or the spring stanchion cup are placed into recessed apertures of the stem. The boot may be over-molded on the spring stanchion cup or molded and placed onto the spring stanchion cup.

This application claims the benefit of the filing date of U.S.Provisional Patent Application Ser. No. 61/418,089, filed on Nov. 30,2010. This entire disclosure is hereby incorporated by reference intothe present disclosure.

FIELD

This application relates to medical instrument systems. Moreparticularly, suction valves for endoscopes and methods formanufacturing such valves.

BACKGROUND

Endoscopes are well-known in the art and are commonly used for numerousmedical procedures. A control section of an endoscope may include asuction cylinder, air/water cylinder, and the like. Valves may beinserted into these cylinders to control various functions of theendoscope.

For example, a suction valve for an endoscope may be inserted into asuction cylinder of the endoscope to provide suction to the endoscope.When the suction valve is in a normal position, air flow from the distaltip of the endoscope is blocked by the valve. When suction is desired,an operator engages the suction valve (e.g. by depressing the valve) toopen the suction channel to create negative pressure that draws air orfluid into the opening of the instrument channel of the endoscope. Whenthe operator releases the suction valve, the valve returns to its normalposition blocking air flow and stops the suctioning.

After each use, an endoscope may undergo cleaning, disinfection,sterilization, and the like to prevent the spread of disease, germs,bacteria, illness, and the like. Many components of an endoscope may bereusable, such as a suction valve, and must also be cleaned,disinfected, and/or sterilized between uses. Unfortunately, there isusually a great expense associated with maintaining sterility of theequipment. Additionally, there exists significant difficulty for accessto the suction valve features to properly disinfect/clean the device.

Reusable suction valves may be assembled from the combination of severalmetal, plastic, and/or rubber components. As such, there is significantcost associated with the manufacturing of reusable suction valves.

Disposable suction valves obviate the need for cleaning, disinfection,and sterilization, thereby eliminating the cost of repeated cleaning,disinfection, and sterilization. Additionally, disposable suction valvesdo not require expensive materials to be utilized to manufacture thevalves, thereby eliminating the high cost of manufacturing suctionvalves from expensive materials.

Thus, there is a need to develop new disposable suction valves andmethods that reduce or eliminate the need for repeated cleaning,disinfection, and sterilization and reduce or eliminate the risk ofinfecting the patient. Suction valves that have reduced risk of cloggingwould also be very useful.

SUMMARY

New devices and methods are provided that reduce or eliminate the riskof contaminating the endoscope and reduce or eliminate the risk ofinfecting the patient. The suction valve provided is lightweight, easyto use and, in some embodiments, improves suction efficiency.

Various embodiments of a disposable suction valve for an endoscope arediscussed herein, including manufacturing processes for disposablesuction valves.

In some embodiments, a disposable suction valve may include a main stemproviding an air passage through the center bore of the main stem. Thedisposable suction valve may also include a spring stanchion cup and aspring. A boot may be over-molded on the exterior of the springstanchion cup.

In some embodiments, the method for manufacturing a disposable suctionvalve may include several steps. A main stem and spring stanchion cupare molded. The bottom end of the main stem is placed through the centerof the spring and spring stanchion cup. A boot may be over-molded to thespring stanchion cup to complete the disposable suction valve.

In some embodiments, there is a suction valve assembly comprising: astem comprising at least one recess and/or projection disposed on thestem, a first opening disposed along a longitudinal axis of the stem,and a second opening disposed transverse to the first opening, the firstand second openings for allowing passage of air and/or fluid; a springstanchion comprising at least one recess and/or projection configured toattach to the recess and/or projection of the stem; the spring stanchioncomprising an opening configured to receive the stem and allow movementof the stem in an upward and downward position; and a spring configuredto contact the spring stanchion and the stem.

In some embodiments, a stem is provided, which significantly reduces thedistal section of the stem below the transverse port of the stem.

Additional features and advantages of various embodiments will be setforth in part in the description that follows, and in part will beapparent from the description, or may be learned by practice of variousembodiments. The objectives and other advantages of various embodimentswill be realized and attained by means of the elements and combinationsparticularly pointed out in the description and appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

In part, other aspects, features, benefits and advantages of theembodiments will be apparent with regard to the following description,appended claims and accompanying drawings where:

FIG. 1 illustrates an isometric view of an embodiment of a disposablesuction valve;

FIG. 2 illustrates a side view of an embodiment of a disposable suctionvalve;

FIG. 3 illustrates a side view and a cross sectional view of anembodiment of a stem;

FIG. 4 a illustrates a side view and a cross sectional view of anembodiment of a stem rotated about 90 degrees;

FIG. 4 b illustrates an embodiment of alternative implementation of astem;

FIG. 4 c illustrates an embodiment of another implementation of a stem;

FIG. 5 illustrates a top view of an embodiment of a spring cup orstanchion cup;

FIG. 6 illustrates a cross sectional view of an embodiment of a springcup or stanchion cup;

FIG. 7 illustrates an isometric view of an embodiment of a boot;

FIG. 8 illustrates a cross sectional view of an embodiment of adisposable suction valve;

FIGS. 9 a and 9 b illustrate embodiments of the general operation of adisposable suction valve in a medical instrument, such as for example,an endoscope; and

FIG. 10 illustrates a flow chart of an embodiment of a manufacturingprocess for a disposable suction valve.

It is to be understood that the figures are not drawn to scale. Further,the relation between objects in a figure may not be to scale, and may infact have a reverse relationship as to size. The figures are intended tobring understanding and clarity to the structure of each object shown,and thus, some features may be exaggerated in order to illustrate aspecific feature of a structure.

DETAILED DESCRIPTION

For the purposes of this specification and appended claims, unlessotherwise indicated, all numbers expressing quantities of ingredients,percentages or proportions of materials, reaction conditions, and othernumerical values used in the specification and claims, are to beunderstood as being modified in all instances by the term “about.”Accordingly, unless indicated to the contrary, the numerical parametersset forth in the following specification and attached claims areapproximations that may vary depending upon the desired propertiessought to be obtained by the present invention. At the very least, andnot as an attempt to limit the application of the doctrine ofequivalents to the scope of the claims, each numerical parameter shouldat least be construed in light of the number of reported significantdigits and by applying ordinary rounding techniques.

Notwithstanding the numerical ranges and parameters set forth herein,the broad scope of the invention are approximations, the numericalvalues set forth in the specific examples are reported as precisely aspossible. Any numerical value, however, inherently contains certainerrors necessarily resulting from the standard deviation found in theirrespective testing measurements. Moreover, all ranges disclosed hereinare to be understood to encompass any and all subranges subsumedtherein. For example, a range of “1 to 10” includes any and allsubranges between (and including) the minimum value of 1 and the maximumvalue of 10, that is, any and all subranges having a minimum value ofequal to or greater than 1 and a maximum value of equal to or less than10, e.g., 5.5 to 10.

Reference will now be made in detail to certain embodiments of theinvention, examples of which are illustrated in the accompanyingdrawings. While the invention will be described in conjunction with theillustrated embodiments, it will be understood that they are notintended to limit the invention to those embodiments. On the contrary,the invention is intended to cover all alternatives, modifications, andequivalents that may be included within the invention as defined by theappended claims.

It is noted that, as used in this specification and the appended claims,the singular forms “a,” “an,” and “the,” include plural referents unlessexpressly and unequivocally limited to one referent. Thus, for example,reference to “a stanchion cup” includes one, two, three or morestanchions cups.

We refer now to the drawings wherein depicted elements are notnecessarily shown to scale and wherein like or similar elements aredesignated by the same reference numeral through the several views.

Referring to the drawings in general, it will be understood that theillustrations are for the purpose of describing particular embodimentsof the disclosure and are not intended to be limiting thereto.

While most of the terms used herein will be recognizable to those ofordinary skill in the art, it should be understood that when notexplicitly defined, terms should be interpreted as adopting a meaningpresently accepted by those of ordinary skill in the art.

FIG. 1 is an isometric view of a disposable suction valve 10. FIG. 2 isa side view of an illustrative embodiment of a disposable suction valve10. While the disposable suction valve 10 shown is suitable for use withOlympus® endoscopes, other embodiments of disposable suction valves maybe suitable for use with other types of endoscopes, such as Pentax®,Fujinon®, or the like. As such, the embodiments discussed herein may bemodified to accommodate other types and/or brands of endoscopes.

Disposable suction valve 10 may provide a stem 15, stem insert 20, boot25, spring cup/stanchion (not shown) and spring 30. One or morecomponents of the disposable suction valve may comprise disposablematerial, including, but not limited to polyurethane, polyurea,polyether(amide), PEBA, thermoplastic elastomeric olefin, copolyester,and styrenic thermoplastic elastomer, carbon fiber, glass fiber,ceramics, methacrylates, poly (N-isopropylacrylamide), PEO-PPO-PEO(pluronics), rubber, plastic (e.g., polycarbonates), ABS, MABS,silicone, or the like or combinations thereof. Stem 15 and stem insert20 may be formed from a suitable material or combination of material(s),such as plastic, polymeric material(s), or the like. Stem insert 20 maybe color coded (e.g. black, red, green, etc.) to indicate the type ofvalve or that the valve is a suction valve. In other embodiments, steminsert 20 may be omitted or color coding may be provided by anothermeans (e.g. painting).

Boot 25 may be formed from a suitable material, such as for example,polyurethane, polyurea, polyether(amide), PEBA, thermoplasticelastomeric olefin, copolyester, and styrenic thermoplastic elastomer,carbon fiber, glass fiber, ceramics, methacrylates, poly(N-isopropylacrylamide), PEO-PPO-PEO (pluronics), rubber, plastic (e.g.,polycarbonates), or the like or combinations thereof.

In one embodiment, boot 25 may be made from a pliable material for easeof assembly e.g., a material that allows boot 25 to be slid over springstanchion cup (not shown) during assembly and to seal off the suction inthe circuit. In other embodiments, boot 25 may be over-molded onto thespring stanchion cup. Spring 30 may be formed from a suitable material,such as corrosion resistant metal, polyurethane, polyurea,polyether(amide), PEBA, thermoplastic elastomeric olefin, copolyester,and styrenic thermoplastic elastomer, carbon fiber, glass fiber,ceramics, methacrylates, poly (N-isopropylacrylamide), PEO-PPO-PEO(pluronics), rubber, plastic, or the like or combinations thereof.

While a spring 30 is shown in FIG. 1 , it will be understood that anyresilient member (e.g., a member that resumes its original shape orposition after being compressed) can be used. A resilient member caninclude, for example, a spring, plastic, rubber or other elastic memberthat allows its original shape or position after being compressed.

The air used for suction in combination with the device can be filteredusing an inline air filter assembly having a porous medium to filterair. This filter may be disposed in the air path exterior of it withinthe suction channel. The porous media can be made of polyethersulfone,PTFE, a PVC, acrylic copolymer, polysulfone, polyvinylidene fluoride,cellulose acetate, cellulose nitrate, mixed esters of cellulose, nylon,polyamide or a combination thereof. The filter can be microporous, andthe mean pore size of the media is from about 0.2 micron to about 150microns. In some embodiments, the filter can have a mean pore size ofabout 0.22 micron to about 0.8 micron.

In contrast, the stem of a re-usable suction valve may be formed fromone or more components made of a material that is suitable for repeatedcleaning, disinfection, and sterilization, such as stainless steel orthe like. While this material allows a re-usable suction valve to berepeatedly cleaned, disinfected, and sterilized for re-use, suchmaterial may be costly; is difficult to properly clean; requires morecomponents; requires additional manufacturing and assembly steps;requires more costly manufacturing processes; and the like. In additionto being more costly to manufacture than a disposable suction valve, are-usable suction valve also requires equipment and materials that areutilized to repeatedly clean, disinfect, and sterilize the valve.

The disposable suction valve of the current application, in someembodiments and as shown in FIG. 4B, improves suction, reduces oreliminates leaks and/or fluid going into and out of unwanted areas ofthe valve or in unwanted areas of the medical instrument. The disposablesuction valve of the current application, in some embodiments, reducesor eliminates debris from clogging the valve.

In some embodiments, unlike the non-disposable seven-component suctionvalves in the prior art, the disposable suction valve of the currentapplication, comprises four components: a stem 15, boot 25, springcup/stanchion (not shown) and spring 30. In some embodiments, unlike thenon-disposable seven-component suction valves in the prior art, thedisposable suction valve of the current application, comprises fivecomponents: a stem 15, boot 25, spring cup/stanchion (not shown), spring30, and stem insert 20.

In some embodiments, the difference from the disposable suction valve ofthe current application and the prior is that in the prior art valveconstruction, the prior art valve has a stem (with a threaded buttonhead end) plus a metal backing plate (to thread onto stem and offer asecure joint for the plastic button head) and a plastic button head. Inthe disposable suction valve of the current application, in someembodiments, the stanchion cup is molded and then the boot is overmoldedonto this piece. Accordingly, in some embodiments, the stanchion cup ismonolithic with the boot (e.g., they are one piece) and therefore, themanufacturing process is simpler. Therefore, the disposable suctionvalve of the current application can be easier to manufacture and thereis less chance of the components malfunctioning when compared to priorart non-disposable seven-component suction valves.

FIG. 3 and FIG. 4 a show cross sectional views of illustrativeembodiments of stem 15 rotated 90 degrees. FIG. 3 and FIG. 4 a also showstem 15 in a side view along longitudinal axis AA. Stem 15 is a singlemolded component of disposable suction valve 10. Stem 15 providesopenings 35 and 40 passing through the stem. Fluid may pass horizontallythrough one side of opening 35 and vertically through opening 40. Thestem 15 is symmetrical for ease of use. Openings 35 and 40 may allow airor fluid to pass through the instrument channel of an endo scope when asuction valve is actuated. Recessed apertures 45 may be utilized tosecure a spring stanchion cup or flange to stem 15. In some embodimentsof stem 15, the stem diameter may be precisely controlled to assure anair tight or nearly air tight seal within the suction cylinder/port ofan endoscope.

FIG. 4 b is an illustrative embodiment of alternative implementation ofa stem 15 b. Stem 15 b has a reduced stem length and includes points 18.Suction valves may clogged due to debris from the body that “plugs” thevertical and horizontal passages of the suction valve stem. By reducingor eliminating, in essence, the “tube” portion of the stem below theopening in the stem, this clogging condition can be drastically reducedor eliminated. Points 18 minimize the contact between stem 15 b and theinterior of the suction cylinder of the endoscope, thereby reducing oreliminating the chances of debris clogging in the stem 15 b jamming inthe endoscope. Points 18 are positioned at a distal end of stem 15.

By reducing the stem length suction efficiency is improved and thepotential for suction valve clogging is reduced or eliminated. In someembodiments, the shorter stem allows the user to press less on the valvein a downward direction to align an opening with the suction channel(not shown). In this way, debris and/or fluid is prevented from cloggingthe suction channels as the distance to align the suction channel withthe opening is shorter. In some embodiments, the stem length is reducedby 10%, 20%, 30%, 40%, 50%, or 60% compared to stems that are fulllength (e.g., full length stems can be 0.95 of an inch).

FIG. 4 c is an illustrative embodiment of another implementation of astem 15 c. Stem 15 c may include an O-ring 17 or any other suitablealternative sealing method, which may be over-molded on stem 15 c orplaced on stem 15 c during assembly. O-ring 17 may seal suction cylinderto prevent air and/or fluids from escaping through suction valve 15 c.O-ring 17 may also include, in some embodiments, mold designconsiderations that provide a substantially or perfectly cylindricalstem and/or fully concentric configuration in order to provide an airtight seal in the endoscope port.

It will be understood that the seal can be any member suitable forsealing a portion of the stem. The seal can be permanently attached tothe stem, such as for example, by over-molding so that is a raisedmember. In some embodiments, the seal can be removably attached to thestem, such as for example, by sliding it on the stem. Like othercomponents of the suction valve, the seal can comprise polyurethane,polyurea, polyether(amide), PEBA, thermoplastic elastomeric olefin,copolyester, and styrenic thermoplastic elastomer, carbon fiber, glassfiber, ceramics, methacrylates, poly (N-isopropylacrylamide),PEO-PPO-PEO (pluronics), rubber, plastic (e.g., polycarbonates), ABS,MABS, silicone or the like or combinations thereof.

Referring to FIG. 5 and FIG. 6 , FIG. 5 is top view of an illustrativeembodiment of a spring stanchion cup 50. FIG. 6 is a cross section viewof an illustrative embodiment of spring stanchion cup 50. Springstanchion cup 50 includes outer ring 55, stem opening 60, extensions 65,tabs 70, and diaphragm 75. Outer ring 55 shown in FIG. 6 provides agenerally cylindrical ring body for spring stanchion cup 50. Stemopening 60 provides an opening for receiving stem 15. Extensions 65extend up from diaphragm 75 of spring stanchion cup 50. Extensions 65extend a predetermined distance from diaphragm 75 and work inconjunction with recessed apertures 45 of FIG. 3 to limit how far stem15 travels when the disposable suction valve (10 of FIG. 3 ) is actuatedor released. Tabs 70 may protrude from the top of extensions 65 towardsstem opening 60. When disposable suction valve 10 is assembled, a springis placed between stem 15 and diaphragm 75 of spring stanchion cup 50.Tabs 70 of spring stanchion cup 50 are placed into recessed apertures 45of stem 15, thereby securing spring stanchion cup 50 to stem 15. Spring30 maintains disposable suction valve 10 in an un-actuated position,unless an operator depresses disposable suction valve 10. In someembodiments, spring stanchion cup 50 may have one or more, recesses,such as for example, cut outs 71 that can be any shape (circular,square, triangle, etc.) to allow for bonding to a boot, such as forexample, boot 25 shown in FIG. 1 and FIG. 2 .

While a spring stanchion cup 50 is shown in FIGS. 5 and 6 , it will beunderstood that any flange can be used to hold a portion of theresilient member (e.g., spring, rubber, etc.) in position that allowsthe resilient member to return to its original shape or position afterbeing compressed.

In some embodiments, spring stanchion cup 50 the cut outs 71 areconfigured to allow for bonding to an over molded boot in a subsequentover molding operation. In some embodiments, the cutouts 71 areconfigured to mate with corresponding projections, recesses or cutoutsof the stem and/or boot to lock the spring stanchion cup 50 to the stemand/or boot. In this way the components are attached to each other. Insome embodiments, the boot 25 creates the seal and, among other things,enhances suction as compared to prior art suction valves by about 10%,15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, or 60% or more, dependingon composition of the bodily fluid suctioned. For example, bodily fluid(e.g., waste, blood, etc.) having a low viscosity like water can besuctioned more than about 12% with the current disposable suction valvewhile higher viscosity bodily fluids that are thicker can be suctionedmore than about 40% with the current disposable suction valve.

In some embodiments, the concentricity of the stem is used to optimizesuction. Therefore, manufacturing methodology that enhancesconcentricity of the stem can provide optimum suction capability.

FIG. 8 shows a cross sectional view and side view of an illustrativeembodiment of an assembled disposable suction valve 10. Stem 15 extendsthrough spring 30 and spring stanchion cup 50. Boot 25 is over-molded orplaced over spring stanchion cup 50. Boot 25 provides a sealing ledge 27that seals off the suction port in the endoscope. For example, the topof stem 15 engages sealing ledge 27 when disposable suction valve 10 isdepressed. In an illustrative embodiment shown in FIG. 7 , boot 25provides a sealing ledge 27 that seals off the suction port in theendoscope. Note that sealing ledge 27 may be placed at any suitableposition on boot 25. Further, sealing ledge 27 may alternatively bedisposed on spring stanchion cup 50. For example, a sealing ledge on theboot or spring stanchion cup may create a seal against stem 15, suctioncylinder, a portion of the endoscope, or the like. Tabs 70 of springstanchion cup 50 reside in recessed apertures 45 of stem 15. Recessedapertures 45 allow the restricted movement of stem 15 up and down onspring stanchion cup 50. The recessed apertures 45, in some embodiments,can be disposed on all or a portion of the stem 15. In some embodiments,the recessed apertures 45 can be disposed on all or a portion of opposedsurfaces of the stem 15.

As shown, spring 30 maintains stem 15 in its upper position, butrecessed apertures 45 and tabs 70 prevent stem 15 from being separatedfrom spring stanchion cup 50. When disposable suction valve 10 isactuated, spring 30 is compressed and stem 15 moves further down intospring stanchion cup 50. Recessed apertures 45 limit how far down stem15 may travel because tabs 70 will eventually come in contact with thetop part of stem 15. In some embodiment, the top part of stem 15 canalso be referred to as a button head or button cap.

FIGS. 9 a and 9 b are illustrative embodiments of the general operationof a disposable suction valve 10 in an endoscope. Disposable suctionvalve 10 may be placed into the suction cylinder of an endoscope. Thesuction channel 85 of the endoscope is linked to the instrument channel80 and leads to the distal end of an endoscope or leads toward thepatient. The endoscope may be connected to a suction pump or the like tocreate negative pressure in the suction channel when a suction valve isactuated. In an un-actuated position shown in FIG. 9 a , opening 35 isout of position with suction channel 85, thereby preventing the suctionpump from creating negative pressure in the suction channel 85. Suctionvalve 10 has not created a seal against sealing ledge 27 in anun-actuated position, which may allow air to enter through suctioncylinder/port of the endoscope through suction valve 10.

For example, disposable suction valve 10 when spring 30 is notcompressed, shown in an un-actuated position in FIG. 8 , may allow airto enter through suction valve 10. Note that stem 15 does not create aseal against spring stanchion cup 50, and stem 15 does not create a sealagainst the cylinder wall of the suction cylinder of the endoscope inthe non-actuated position. When an operator actuates disposable suctionvalve 10 (e.g. depressing stem 15 and compressing spring 30), opening 35moves into position with the suction channel 85 from the distal end ofthe endoscope or from the patient as shown in FIG. 9 b . Further,disposable suction valve 10 creates a seal between the stem 15 andsealing ledge 27 when actuated.

By aligning opening 35 with the suction pathway from the patient andsealing the suction cylinder of the endoscope, the negative pressurecreated by a suction pump or the like cause flow from the distal end ofthe endoscope towards the suction connection as shown in FIG. 9 b . As aresult, air and/or fluid may be suctioned from the distal end of theendoscope when disposable suction valve 10 is in an actuated position.When the operator releases the suction valve, spring 30 causesdisposable suction valve 10 to return to the un-actuated position shownin FIG. 9 a.

This procedure of aligning opening 35 with the suction pathway from thepatient and sealing the suction cylinder of the endoscope, the negativepressure created by a suction pump or the like cause flow from thedistal end of the endoscope towards the suction connection as shown inFIG. 9 b can be accomplished with various suction valves and/orcomponents, for example, those described in FIGS. 1-7 . As a result, airand/or fluid may be suctioned from the distal end of the endoscope whendisposable suction valve 10 is in an actuated position. When theoperator releases the stem 15 of the suction valve 10, spring 30 causesdisposable suction valve 10 to return to the un-actuated position shownin FIG. 9 a.

Although the suction valve is designed to be used with an endoscope, itwill be understood that other medical instruments can be used with thepresent suction valve or assembly. These instruments include, forexample, colonoscopes, laparoscopes, bronchoscopes, or any medicalinstruments with a camera that requires suctioning.

In some embodiments, there is a method for manufacturing a disposablesuction valve comprising: molding a stem; molding a flange for aresilient member; placing a bottom end of the stem through the center ofthe resilient member; placing the bottom end of the stem through a stemopening in the flange for the resilient member; and placing tabs of theflange for the resilient member into recessed apertures of the stem.

In some embodiments, there is a disposable suction valve wherein thestanchion or flange is monolithic with the boot (e.g., they are onepiece).

In some embodiments, there is a suction valve assembly comprising: astem comprising a first opening disposed along a longitudinal axis ofthe stem, and a second opening disposed transverse to the first opening,the first and second openings for allowing passage of air and/or fluid;a flange for a resilient member comprising at least one recess and/orprojection configured to attach to the stem; the flange comprising anopening configured to receive the stem and allow movement of the stem inan upward and downward position relative to the flange; and theresilient member configured to contact the flange and the stem.

In some embodiments, there is a suction valve assembly comprising: astem comprising a first opening disposed along a longitudinal axis ofthe stem, and a second opening disposed transverse to the first opening,the first and second openings for allowing passage of air and/or fluid;a flange for supporting a resilient member comprising at least onerecess and/or projection configured to attach to the stem; the flangecomprising an opening configured to receive the stem and allow movementof the stem in an upward and downward position relative to the flange;and the resilient member configured to contact the flange and the stem.

FIG. 10 illustrates a flow chart of a manufacturing process for adisposable suction valve. In contrast to disposable suction valves, are-usable suction valve may include metal components that are suitablefor repeated cleaning, disinfection, and sterilization. These metalcomponents may require more costly manufacturing and complicatedassembly than the components of a disposable suction valve. For example,metal components may manufactured by precision machining/grinding,threading, stamping, machine pressing, or the like. Further, duringassembly, the metal components may need to be welded together, gluedusing an adhesive, or the like. These steps may complicate manufacturingand increase cost.

A disposable suction valve provides a low cost manufacturing andsimplified assembly process, thereby significantly reducing the cost ofsuction valve. The low cost materials, manufacturing processes, andassembly process of disposable suction valves provides an alternative toutilizing costly re-usable suction valve. Further, disposable suctionvalves allow the number of components to be reduced.

In step S10, a stem is molded using a suitable molding process, such asinjection molding or the like. In step S20, a spring stanchion cup ismolded using a suitable thermoplastic processing techniques, such as,for example, injection molding, rotational molding, or the like,extrusion techniques (for example, extrusion, co-extrusion, multi-layerextrusion, and so forth) and casting.

Stem and spring stanchion cup are formed from a suitable material suchas for example, polyurethane, polyurea, polyether(amide), PEBA,thermoplastic elastomeric olefin, copolyester, styrenic thermoplasticelastomer, carbon fiber, glass fiber, ceramics, methacrylates, poly(N-isopropylacrylamide), PEO-PPO-PEO (pluronics), rubber, plastic (e.g.,polycarbonates), ABS, MABS, silicone, or the like or combinationsthereof. Stem and spring stanchion cup may be formed from a rigidmaterial that is capable of withstanding forces exerted on a suctionvalve by an operator.

In another embodiment of the manufacturing process, the stem and springstanchion may be formed by ultrasonically welding molded pieces. A bootmay be molded or assembled onto spring stanchion cup in step S30. Theboot may be injection molded, over molded on the spring stanchion cup,or molded using any suitable molding process. When boot is moldedseparately, the boot may also be assembled on the spring stanchion cupduring step S30. The boot is formed from a suitable material orcombination of material(s), such as rubber, plastic, polymericmaterial(s), or the like. In steps S40 and S50, the bottom of the stemis placed through the center of a spring and the stem opening in thespring stanchion cup. Next, spring stanchion cup tabs are placed intorecess apertures of the stem in step S60 to complete the assembly of thedisposable suction valve.

It will be recognized by one of ordinary skill in the art that numeroussteps in the manufacturing process may be optional or may be performedin a different sequence than specifically shown. The scope of themanufacturing process is not limited to the particular sequence andsteps discussed herein, except as expressly recited in the claims. Forexample, it should be noted that the boot may be provided at varioussteps in the manufacturing process. In other embodiments of themanufacturing process, the boot may be assembled onto spring stanchioncup as the last step in the manufacturing process. Further, the stem andthe spring stanchion cup may be molded simultaneously or in a sequencedifferent than shown.

The suction valve may be sterilizable. In various embodiments, one ormore components of the suction valve are sterilized by radiation in aterminal sterilization step in the final packaging. Terminalsterilization of a product provides greater assurance of sterility thanfrom processes such as an aseptic process, which require individualproduct components to be sterilized separately and the final packageassembled in a sterile environment.

Typically, in various embodiments, gamma radiation is used in theterminal sterilization step, which involves utilizing ionizing energyfrom gamma rays that penetrates deeply in the device. Gamma rays arehighly effective in killing microorganisms, they leave no residues norhave sufficient energy to impart radioactivity to the device. Gamma rayscan be employed when the device is in the package and gammasterilization does not require high pressures or vacuum conditions,thus, package seals and other components are not stressed. In addition,gamma radiation eliminates the need for permeable packaging materials.

In various embodiments, electron beam (e-beam) radiation may be used tosterilize one or more components of the device. E-beam radiationcomprises a form of ionizing energy, which is generally characterized bylow penetration and high-dose rates. E-beam irradiation is similar togamma processing in that it alters various chemical and molecular bondson contact, including the reproductive cells of microorganisms. Beamsproduced for e-beam sterilization are concentrated, highly-chargedstreams of electrons generated by the acceleration and conversion ofelectricity.

Other methods may also be used to sterilize one or more components ofthe device, including, but not limited to, gas sterilization, such as,for example, with ethylene oxide or steam sterilization.

In various embodiments, a kit is provided that may include additionalparts along with the suction valve combined together to be used with thesuction valve. The kit may include the suction valve device in a firstcompartment. The second compartment may include a canister holding thesuction valve and any other instruments needed for the procedure. Athird compartment may include gloves, drapes, wound dressings and otherprocedural supplies for maintaining sterility, as well as an instructionbooklet. A fourth compartment may include additional cannulas and/orneedles. A fifth compartment may include an agent for radiographicimaging. Each device may be separately packaged in a plastic pouch thatis radiation sterilized. A cover of the kit may include illustrations ofthe use of the device and a clear plastic cover may be placed over thecompartments to maintain sterility.

Implementations described herein are included to demonstrate particularaspects of the present disclosure. It should be appreciated by those ofskill in the art that the implementations described herein merelyrepresent exemplary implementation of the disclosure. Those of ordinaryskill in the art should, in light of the present disclosure, appreciatethat many changes can be made in the specific implementations describedand still obtain a like or similar result without departing from thespirit and scope of the present disclosure. From the foregoingdescription, one of ordinary skill in the art can easily ascertain theessential characteristics of this disclosure, and without departing fromthe spirit and scope thereof, can make various changes and modificationsto adapt the disclosure to various usages and conditions. Theimplementations described hereinabove are meant to be illustrative onlyand should not be taken as limiting of the scope of the disclosure,which is defined in the following claims.

From the foregoing description, one of ordinary skill in the art caneasily ascertain the essential characteristics of this disclosure, andwithout departing from the spirit and scope thereof, can make variouschanges and modifications to adapt the disclosure to various usages andconditions. The implementations described hereinabove are meant to beillustrative only and should not be taken as limiting of the scope ofthe disclosure, which is defined in the following claims.

What is claimed is:
 1. A suction valve assembly consisting essentiallyof a stem having at least one opening and at least one recessedaperture, a stem insert, a boot, a spring stanchion, and a spring suchthat the at least one recessed aperture is surrounded by the spring andthe spring stanchion.
 2. The suction valve assembly of claim 1, whereinthe stem comprises a first opening disposed along a longitudinal axis ofthe stem, and a second opening disposed transverse to the first opening,the first and second openings for allowing passage of air and/or fluid.3. The suction valve assembly of claim 1, wherein the spring stanchioncomprises an outer ring and an opening configured to receive the stemand allow movement of the stem in an upward and downward positionrelative to the spring stanchion.
 4. The suction valve assembly of claim1, wherein the spring stanchion comprises a diaphragm and an extensioncomprising a tab.
 5. The suction valve assembly of claim 4, wherein thespring contacts the diaphragm.
 6. The spring stanchion assembly of claim1, wherein the spring stanchion is molded as a single monolithic piececomprising at least one projection configured to attach to the stem. 7.The suction valve assembly of claim 1, wherein the spring is configuredto contact the spring stanchion and the stem.
 8. The suction valveassembly of claim 1, wherein the at least one recessed aperture engagesthe spring stanchion, and the recessed aperture is configured to definethe bounds of movement for the stem.
 9. A suction valve assemblycomprising a stem, the stem comprising a first opening disposed along alongitudinal axis of the stem, and a second opening disposed transverseto the first opening, the first and second openings for allowing passageof air and/or fluid; a spring stanchion comprising at least one recessand/or projection configured to attach to the stem; the spring stanchioncomprising an opening configured to receive the stem and allow movementof the stem in an upward and downward position relative to the springstanchion; a spring configured to contact the spring stanchion and thestem, the stem comprising at least one recessed aperture to engage thespring stanchion, the recessed aperture configured to define the boundsof movement for the stem; and a boot configured to be attached to thespring stanchion and configured to be contacted by the stem when thestem is moved in the downward position.
 10. A suction valve assemblyaccording to claim 9, wherein the opening in the spring stanchion isdisposed in a center of the spring stanchion and the spring stanchioncomprises a ledge to receive a first end of the spring and the stemcomprises a ledge to receive the second end of the spring.
 11. A suctionvalve assembly according to claim 9, wherein the boot comprises a ledgeconfigured to receive a button head portion of the stem to provide anairtight seal when a top portion of the stem contacts the ledge of theboot.
 12. A suction valve assembly according to claim 9, wherein (i) thestem comprises a plurality of points at one end, and a top portion or abutton head at an opposite end configured to be contacted by a finger;(ii) the stem comprises a projection comprising a sealing member toassure a proper seal within a suction port of a medical device; and(iii) the stem comprises an O-ring attached thereto to assure a properseal within a suction port of a medical device.
 13. A suction valveassembly according to claim 9, wherein the stem, and spring stanchioncomprise disposable thermoplastic material.
 14. A suction valve assemblyaccording to claim 9, wherein the stem has a diameter that is concentricto the diameter of the boot to assure an airtight seal within a suctionport of a medical device.
 15. A suction valve assembly according toclaim 9, wherein the first opening contacts the second opening, and whenthe stem is pressed in a downward direction, the second opening alignswith a suction channel of a medical instrument and allows passage of airand/or fluid to a suction connection.
 16. A suction valve assemblyaccording to claim 9, wherein the stem further comprises a secondrecessed aperture between the first opening and the second opening, thesecond recessed aperture being disposed about the stem.